An Analytical Legislative History Of The Medical Device Amendments Of 1976
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An Analytical Legislative History Of The Medical Device Amendments Of 1976
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Author : Daniel F. O'Keefe
language : en
Publisher:
Release Date : 1976
An Analytical Legislative History Of The Medical Device Amendments Of 1976 written by Daniel F. O'Keefe and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1976 with Law categories.
The Medical Device Industry
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Author : Norman F. Estrin
language : en
Publisher: CRC Press
Release Date : 1990-08-31
The Medical Device Industry written by Norman F. Estrin and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1990-08-31 with Medical categories.
Practical information about the complexities of biomedical technology and regulation, and their implications for manufacturers and marketers of health care devices. Written primarily for those in the industry concerned about staying competitive in light of complex and fluctuating regulatory approach
Medical Devices And The Public S Health
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-10-25
Medical Devices And The Public S Health written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-10-25 with Medical categories.
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Public Health Effectiveness Of The Fda 510 K Clearance Process
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2010-10-04
Public Health Effectiveness Of The Fda 510 K Clearance Process written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-10-04 with Medical categories.
The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Current Catalog
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Author : National Library of Medicine (U.S.)
language : en
Publisher:
Release Date : 1979
Current Catalog written by National Library of Medicine (U.S.) and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1979 with Medicine categories.
First multi-year cumulation covers six years: 1965-70.
Federal Register
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Author :
language : en
Publisher:
Release Date : 1978-08
Federal Register written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1978-08 with Delegated legislation categories.
Food And Drug Administration Advisory Committees
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 1992-02-01
Food And Drug Administration Advisory Committees written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992-02-01 with Medical categories.
Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.
Safe Medical Devices For Children
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2006-01-20
Safe Medical Devices For Children written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-01-20 with Medical categories.
Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.
Technological Innovation
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Author : Annetine C. Gelijns
language : en
Publisher: National Academies
Release Date : 1989
Technological Innovation written by Annetine C. Gelijns and has been published by National Academies this book supported file pdf, txt, epub, kindle and other format this book has been release on 1989 with Clinical medicine categories.
Modern Methods Of Clinical Investigation
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 1990-02-01
Modern Methods Of Clinical Investigation written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1990-02-01 with Medical categories.
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.